CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Post-intervention arm = Prehabilitationbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02292927
NCT02292927N/ACompleted

Maximising Recovery to Health Through Trimodal (Bio Psycho Social) Prehabilitation for Aneurysm Surgery Study

Imperial College London·interventional·Posted Nov 18, 2014·Updated Jul 17, 2019

In Brief

A clinical study evaluating Post-intervention arm = Prehabilitation for Aortic Aneurysm. Completed, enrolled 25 participants.

Detailed Summary

DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation program in a cohort of patients undergoing aneurysm repair. This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial. Expected outcomes * The potential number of patients who would benefit, the compliance and acceptability of a pre-operative prehabilitation programme will be calculated. * Preoperatively, expected at 6-weeks, the change in physical fitness of patients (assessed by the physical function section of SF-36 and measured with peak flow/6-minute walk testing) during the pre-operative phase will be assessed in both groups. * The effects on quality of life, anxiety and depression on each study participant will be assessed immediately pre-op, expected at 6-weeks. * The number of patients who are able to reduce or cease smoking will be reported during the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic surgery, expected at 6-8 weeks. POPULATION: Patients undergoing planned elective aortic surgery procedures ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative exercise programme DURATION: 1 year from 1st June 2014

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Aneurysm
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.6 years ago

Interventions

Post-intervention arm = Prehabilitationbehavioral

Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice